Micro-Craft Oscillating Saw Handpiece
FDA 510(k) K822790 · Xomed, Inc.
510(k) numberK822790
Submission
- Device name
- Micro-Craft Oscillating Saw Handpiece
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- September 15, 1982
- Decision date
- October 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
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| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Micro-Craft Oscillating Saw Handpiece cleared by the FDA?
Micro-Craft Oscillating Saw Handpiece (K822790) received a 510(k) decision of Substantially Equivalent on October 22, 1982, 37 days after the submission was received.
What is the product code of K822790?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.